Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 30
- Latest Decision
- 2024-08-26
Clearances · page 6 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240982 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2024-08-26 |
| K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw | Proimtech Saglik Urunleri Anonim Sirketi | DZE | Class II | 2024-08-23 |
| K231932 | TDS (TECHWIN DENTAL SYSTEM) | Techwin Co., Ltd. | NHA | Class II | 2024-08-20 |
| K242432 | MT-Bone | Mectron S.P.A. | DZI | Class II | 2024-08-19 |
| K240573 | iTero Lumina Pro | Align Technology , Ltd. | NTK | Class II | 2024-08-16 |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus | Jdentalcare Srl | DZE | Class II | 2024-08-16 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | JEY | Class II | 2024-08-16 |
| K240133 | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | NPM | Class II | 2024-08-16 |
| K240837 | TOV Dental Implant System | Rdj Tov Implant, Ltd. | DZE | Class II | 2024-08-15 |
| K222688 | The Trust | Genoss Co., Ltd. | EKX | Class I | 2024-08-09 |
| K233844 | OdneClean | Odne AG | ELC | Class II | 2024-08-08 |
| K233356 | Illusion Aligner Pro: Illusion Aligner FLX | Laxmi Dental Export Pvt., Ltd. | NXC | Class II | 2024-08-08 |
| K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | EBZ | Class II | 2024-08-01 |
| K241137 | Clear Moves Aligner | Clear Moves Aligners | NXC | Class II | 2024-08-01 |
| K233808 | LW Narrow Implant System | Ossvis Co., Ltd. | DZE | Class II | 2024-07-31 |
| K241963 | WERAY | Picopack Co., Ltd. | EHD | Class II | 2024-07-30 |
| K240446 | Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + | Shiva Products | KIF | Class II | 2024-07-30 |
| K240531 | SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment | BioHorizons Implant Systems, Inc. | NHA | Class II | 2024-07-30 |
| K241187 | Alien Aligners | Alien Milling Technologies | NXC | Class II | 2024-07-26 |
| K233563 | Navident | Claronav, Inc. | PLV | Class II | 2024-07-25 |
| K241063 | s-Clean ScanHealing Abutment | Dentis Co., Ltd. | NHA | Class II | 2024-07-25 |
| K230305 | THE Graft Collagen | Purgo Biologics, Inc. | NPM | Class II | 2024-07-24 |
| K240714 | Insure® Universal; Insure® Universal Automix | Cosmedent, Inc. | EMA | Class II | 2024-07-24 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | EKX | Class I | 2024-07-24 |
| K241445 | K-Bond Universal | Spident Co., Ltd. | KLE | Class II | 2024-07-22 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | EBG | Class II | 2024-07-19 |
| K233768 | Papacarie Duo | Elevate Oral Care | LBH | Class II | 2024-07-18 |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | DZI | Class II | 2024-07-18 |
| K240609 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2024-07-17 |
| K241056 | Light Cure Adhesive | Sincera Technology (Changchun) Co., Ltd. | KLE | Class II | 2024-07-16 |
| K241032 | BellaTek Bars | Biomet 3i, LLC | NHA | Class II | 2024-07-15 |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | 2024-07-12 |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2024-07-12 |
| K240661 | Geistlich Bio-Oss® | Geistlich Pharma AG | NPM | Class II | 2024-07-12 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | JEY | Class II | 2024-07-12 |
| K233874 | tmCMF Solution | Techmah Cmf | JEY | Class II | 2024-07-11 |
| K240966 | Prima Plus Conical Implant System | Keystone Dental, Inc. | DZE | Class II | 2024-07-09 |
| K241316 | Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd. | EIH | Class II | 2024-07-09 |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | EKX | Class I | 2024-07-09 |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | EHD | Class II | 2024-07-05 |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | MUH | Class II | 2024-07-05 |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | Shenzhen Micro Electric Intelligence Co., Ltd. | ELC | Class II | 2024-07-02 |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | ELC | Class II | 2024-07-01 |
| K241204 | TopCEM-Veneer Light Cure Veneer Cement | Rizhao Huge Biomaterials Company, Ltd. | EMA | Class II | 2024-06-28 |
| K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG | EBF | Class II | 2024-06-27 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | EBW | Class I | 2024-06-24 |
| K232952 | Copran Zri | Whitepeaks Dental Solutions GmbH | EIH | Class II | 2024-06-24 |
| K233885 | rainbow Paste Stain SE | Genoss Co., Ltd. | EIH | Class II | 2024-06-21 |
| K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI | Class II | 2024-06-20 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | EBW | Class I | 2024-06-20 |
| K233158 | Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH | EIH | Class II | 2024-06-20 |
| K241412 | Invisalign System | Align Technology, Inc. | NXC | Class II | 2024-06-18 |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | LBH | Class II | 2024-06-13 |
| K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Zhejiang Zahndent Biotechnology Co., Ltd. | EIH | Class II | 2024-06-07 |
| K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2024-06-07 |
| K240202 | Conical Platform Dental Implants System | Noris Medical , Ltd. | DZE | Class II | 2024-06-06 |
| K240603 | Ti-Base & Master Fix | Arum Dentistry Co., Ltd. | NHA | Class II | 2024-06-05 |
| K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | DZE | Class II | 2024-06-05 |
| K233587 | LOCATOR Angled Abutment (Various) | Zest Anchors, LLC | NHA | Class II | 2024-06-03 |
| K232821 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2024-05-31 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | EBG | Class II | 2024-05-31 |
| K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | EIH | Class II | 2024-05-31 |
| K233389 | EK Digital Abutments | Hiossen, Inc. | NHA | Class II | 2024-05-29 |
| K240304 | Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) | Enpuno Biotechnology Co., Ltd. | KIF | Class II | 2024-05-28 |
| K233285 | KATANA Zirconia ONE For IMPLANT | Kuraray Noritake Dental, Inc. | NHA | Class II | 2024-05-24 |
| K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | DZE | Class II | 2024-05-24 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | EBG | Class II | 2024-05-23 |
| K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. | DZE | Class II | 2024-05-22 |
| K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. | DZE | Class II | 2024-05-20 |
| K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | Hunan Ceramaster Material Technology Co., Ltd. | EIH | Class II | 2024-05-20 |
| DEN230035 | DentalMonitoring | Dental Monitoring Sas | SBC | Class II | 2024-05-17 |
| K233137 | Ticare Dental Implant Systems | Mozograu S.A. | DZE | Class II | 2024-05-16 |
| K233625 | RAYDENT SW | Ray Co., Ltd. | PNN | Class II | 2024-05-16 |
| K240059 | FAgamin® | Tedequim Srl | PHR | Class II | 2024-05-16 |
| K240328 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | QNO | Class II | 2024-05-16 |
| K231940 | BruxZir® NOW SRC | Prismatik Dentalcraft, Inc. | NHA | Class II | 2024-05-15 |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | EHD | Class II | 2024-05-13 |
| K240365 | Bioceramic Root Repair Material (C-Root BP) | Beijing C-Root Dental Medical Devices Co., Ltd. | KIF | Class II | 2024-05-10 |
| K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | NHA | Class II | 2024-05-09 |
| K232025 | Hushd Pro Avera | Good Sleep CO Pte , Ltd. | LRK | Class II | 2024-05-09 |
| K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | Dentsply Sirona | NHA | Class II | 2024-05-07 |
| K232735 | EMA 3D | Ema Sleep Incorporated | LRK | Class II | 2024-05-03 |
| K233857 | Neodent Implant System Custom Abutments | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2024-05-02 |
| K231722 | SmarTooth | Smartooth Co., Ltd. | NBL | Class II | 2024-05-01 |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | NPL | Class II | 2024-05-01 |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | EIH | Class II | 2024-05-01 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | JEY | Class II | 2024-04-30 |
| K232528 | Protective Cap | Neobiotech Co., Ltd. | NHA | Class II | 2024-04-30 |
| K233231 | Dental Implants and Abutments | Ditron Dental, Ltd. | DZE | Class II | 2024-04-30 |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | EFB | Class I | 2024-04-30 |
| K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2024-04-26 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | EFB | Class I | 2024-04-25 |
| K231142 | Temporis, Irix Plus | Dws S.R.L. | EBF | Class II | 2024-04-25 |
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2024-04-24 |
| K233850 | Difiney Anti Snoring Device | Fissiontech, LLC | LRK | Class II | 2024-04-18 |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | MUH | Class II | 2024-04-18 |
| K223113 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments | Medentika GmbH | NHA | Class II | 2024-04-15 |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication | EIH | Class II | 2024-04-12 |
| K221847 | Ni2 Implant System | Newton Implant Systems, Inc. | DZE | Class II | 2024-04-11 |
| K233935 | DigiLine Direct Print Aligner System | Park Dental Research Corporation | NXC | Class II | 2024-04-05 |
12,679 clearances in the Dental panel. Data: openFDA.